Health Condition 1: G892- Chronic pain, not elsewhere classified
Conditions
Interventions
Intervention1: Fixed Dose Combination of Pregabalin & Amitriptyline: 75+25 mg
Dosage : 1 Tablet to be taken twice a day with appropriate 12 hours apart.
Administration : Drink a full glass of water wi
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients of 18 to 65 years of age Newly diagnosed treatment naïve patients with moderate to severe nerve pain for at least 03 months due to one of the following conditions: Post herpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy Moderate to severe pain: Patients having total pain intensity rating of at least 4 on a 0-10 points numeric rating scale Patients having diabetes should have a history of diabetes for at least 6 months Patients with other secondary neuropathies should be stable for at least 3 months Patients having presence of pain for at least 4 days a week Patients with creatinine clearance of at least 60 mL/min Patients who are agree not to use any other approved or experimental pharmacological treatmentsfor neuropathic pain, other than mentioned in the protocol, at any time during the study Patient or his legally accepted representative is willing to give informed consent Female participants of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The "calendar method," withdrawal, or an IUD is NOT an acceptable method. Patients willing to follow the study protocol
Exclusion criteria
Exclusion criteria: Breast feeding or pregnant females History of hepatitis B, hepatitis C or HIV infection History of use of MAO inhibitors, Cisapride, any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas within 02 weeks prior to randomization. Patients who, in the opinion of the investigator, have history of clinically significant cardiovascular disease (ex. MI), central nervous system disorders (ex. Seizure, Bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), severe hepatic and renal impairment, neoplastic disease, suicidal behavior, angle closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension and diabetes or abnormal ECG or the participant has any other abnormal laboratory value of clinical significance for this study. Patients with known alcohol or other substance abuse within last one year Participant has hypersensitivity, intolerance, or contraindication to the use of Amitriptyline and Pregabalin, or any of its components. Patient received treatment with an investigational device or compound within 30 days of the study start Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participantâ??s inability to understand and comply with the requirements of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Numeric Rating Scale (NRS) from baseline to 12 weeksTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Neuropathic Pain Scale (NPS) from baselineTimepoint: 08 & 12 weeks;Change in Numeric Rating Scale (NRS) from baselineTimepoint: 04 and 08 weeks;Clinician Global Impression of Improvement (CGI-I)Timepoint: 08 & 12 weeks;Consumption of rescue medication (number of paracetamol tablets consumed)Timepoint: 08 & 12 weeks;Patient Global Impression of Improvement (PGI-I)Timepoint: 08 & 12 weeks;Proportion of participants with adverse events and serious adverse eventsTimepoint: Baseline, 04, 08 and 12 weeks;Responder rate from baselineTimepoint: 08 & 12 weeks Note: Reduction of 2 points or 30% improvement in NRS | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma laboratories Limited (SPLL)
Outcome results
None listed